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New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting
Date:4/29/2009

d, randomized, parallel-group study conducted in 156 patients with early PD on stable dose of pramipexole immediate release:

  • Patients were randomized overnight to the pramipexole once-daily, extended release or to the pramipexole immediate release formulation (2:1 ratio). Primary efficacy endpoint was the proportion of patients successfully switched (no worsening of UPDRS II+III >15 percent from baseline and no drug-related adverse event leading to withdrawal). 95.5 percent of patients completed the trial, of which 84.5 percent were successfully switched (with or without dose adaptation) to the once-daily formulation. Mean pramipexole extended release dosage increased from 2.63 to 2.75mg/d (a ratio of 1:1.05) and mean pramipexole immediate release dosage from 2.74 to 2.83mg/d (a ratio of 1:1.03); these data support a 1:1 switch from pramipexole immediate release to pramipexole extended release.

In both studies, adverse events observed in patients receiving pramipexole extended release were similar to those seen in previous studies with immediate release pramipexole.

About Parkinson's disease

Parkinson's disease is a progressive neurological disorder that affects nearly one million people in the U.S. It is the second most common chronic neurological disorder in older adults after Alzheimer's. Every nine minutes someone is diagnosed with Parkinson's disease. Symptoms include tremor, muscle rigidity, slowed motion, shuffling gait, and a loss of facial expression. The symptoms vary from individual to individual, but become more severe over time. Although promising research is being conducted, there is currently no cure for Parkinson's disease.

About pramipexole

Pramipexole dihydrochloride tablets, in an immediate release formulation, are indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parki
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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